Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL)

This study has been withdrawn prior to enrollment.
(Funding was withdrawn due to insufficient accrual)
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00758693
First received: September 19, 2008
Last updated: January 10, 2012
Last verified: September 2011
  Purpose

Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Bendamustine
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia: A Phase II Study

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Determine the response rate [ Time Frame: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe the toxicity rates and severities [ Time Frame: Up to 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Describe the quality of life participants experience while receiving this combination therapy [ Time Frame: Up to 2 years after enrollment ] [ Designated as safety issue: No ]
  • Determine the health utility scores of participants while receiving this combination therapy [ Time Frame: Up to 2 years after enrollment ] [ Designated as safety issue: No ]
  • Conduct exploratory analyses of associations between clinical responses and protein expression and phosphorylation using novel flow cytometry methods [ Time Frame: Pre and Post treatment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bendamustine + Rituximab
Drug: Bendamustine
Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles
Other Name: Treanda
Drug: Rituximab
Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles
Other Name: Rituxan

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed chronic lymphocytic leukemia.
  • A minimum of any one of the following disease-related symptoms must be present:

    • Weight loss ≥10% within the previous 6 months.
    • Extreme fatigue (ie, ECOG PS 2; cannot work or unable to perform usual activities).
    • Fevers of greater than 100.5"F for ≥ 2 weeks without evidence of infection.
    • Night sweats without evidence of infection. or
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia or
    • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy or
    • Massive (ie, >6 cm below the left costal margin) or progressive splenomegaly or
    • Massive nodes or clusters (ie, > 10 cm in longest diameter) or progressive lymphadenopathy or
    • Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months but
    • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy
  • No prior therapy for CLL is allowed. Participants may have taken corticosteroids previously but must be ≥ 28 days from last dose prior to enrolment.
  • Age >65 years.
  • Life expectancy of greater than 1 year.
  • ECOG performance status better than or equal 2.
  • Patients must have normal organ and marrow function as defined below:

    • total bilirubin within normal institutional limits unless resulting from documented hemolysis
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had previous chemotherapy or radiotherapy for the treatment of CLL.
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bendamustine or rituximab.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Patients with a known history of viral hepatitis, with the exception of Hepatitis A that has recovered.
  • Patients who require concomitant treatment with CYP1A2 inhibitors including: Cimetidine, Ciprofloxacin, Fluvoxamine, Ticlopidine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758693

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Cephalon
Investigators
Principal Investigator: John Hayslip, MD, MSCR University of Kentucky
  More Information

Additional Information:
No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00758693     History of Changes
Other Study ID Numbers: 08-LEUK-07-MCC/CI
Study First Received: September 19, 2008
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Chronic Lymphocytic Leukemia
Bendamustine
Treanda
Rituximab
Rituxan

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Rituximab
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014